Approval based on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.

2024年2月16日，根据第三阶段试验结果显示，与安慰剂相比，Dupixent显着减少瘙痒CSU是日本第五个批准的Dupixent适应症，也是Dupixent全球第六个适应症TARRYTOWN，N.Y.和巴黎（Global NEWSWIRE）——Regeneron Pharmaceuticals，Inc。

(NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy.

（NASDAQ:REGN）和赛诺菲（Sanofi）今天宣布，日本厚生劳动省（MHLW）已批准Dupixent®（dupilumab）的上市和生产许可，用于治疗12岁及以上的慢性自发性荨麻疹（CSU），其疾病无法通过现有疗法得到充分控制。

Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.

日本是第一个批准Dupixent用于CSU的国家，强调Dupixent作为一种新的治疗选择的价值，以管理未满足需求的患者的这种疾病。CSU是一种慢性炎症性皮肤病，部分由2型炎症驱动，导致突然和衰弱的荨麻疹和持续的瘙痒。

CSU is typically treated with histamine-1 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life.

CSU通常用组胺-1（H1）抗组胺药治疗，这种药物靶向细胞上的H1受体以控制荨麻疹的症状。然而，尽管许多患者接受了抗组胺药治疗，但这种疾病仍然不受控制，其中一些患者的替代治疗选择有限。这些人继续经历可能使人衰弱并严重影响其生活质量的症状。

Approximately 110,000 people aged 12 years and older suffer from uncontrolled moderate-to-severe CSU in Japan, for which there are currently limited treatments. The Japanese approval is based primarily on data from Study A of the LIBERTY-CUPID clinical trial program evaluating Dupixent as an add-on therapy to standard-of-care H1 antihistamines compared to antihistamines alone (placebo) in 138 patients wit.

在日本，大约110000名12岁及以上的人患有不受控制的中度至重度CSU，目前治疗方法有限。日本的批准主要基于LIBERTY-CUPID临床试验计划研究A的数据，该研究评估了Dupixent作为标准治疗H1抗组胺药的附加疗法，与单独使用抗组胺药（安慰剂）的138例患者相比。